Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation. The goals of this study are to learn: * How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Oral administration
Intravenous administration
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 76 months
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 76 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 76 months
Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to approximately 76 months
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Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, United States
RECRUITINGSTART Midwest ( Site 1103)
Grand Rapids, Michigan, United States
RECRUITINGSTART Mountain Region ( Site 1106)
West Valley City, Utah, United States
RECRUITINGVirginia Cancer Specialists ( Site 1102)
Fairfax, Virginia, United States
RECRUITINGRigshospitalet ( Site 1403)
Copenhagen, Capital Region, Denmark
RECRUITINGOdense Universitetshospital ( Site 1401)
Odense, Region Syddanmark, Denmark
RECRUITINGUniversitätsklinikum Jena ( Site 1603)
Jena, Thuringia, Germany
RECRUITINGEmek Medical Center ( Site 1800)
Afula, Israel
RECRUITINGHadassah Medical Center ( Site 1801)
Jerusalem, Israel
RECRUITINGSourasky Medical Center ( Site 1802)
Tel Aviv, Israel
RECRUITING...and 14 more locations
Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 76 months
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. OS will be presented.
Time frame: Up to approximately 76 months